CILOSTAZOL TARBIS 100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cilostazol Tarbis 100 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Cilostazol Tarbis and what is it used for
2. What you need to know before you take Cilostazol Tarbis
3. How to take Cilostazol Tarbis
4. Possible side effects
5. Storage of Cilostazol Tarbis
6. Contents of the pack and other information

1. What is Cilostazol Tarbis and what is it used for

Cilostazol Tarbis belongs to a group of medicines known as phosphodiesterase 3 inhibitors.

It has several actions, including the dilation of certain blood vessels and the reduction of the clotting activity (aggregation) of certain blood cells, called platelets, in the blood vessels.

You have been prescribed Cilostazol Tarbis for "intermittent claudication". Intermittent claudication is the pain in the legs when walking that is caused by insufficient blood supply to the legs. Cilostazol Tarbis may help you increase the distance you can walk, as it improves blood flow to the legs. Cilostazol is only recommended for patients whose symptoms have not improved sufficiently after making lifestyle changes (such as stopping smoking and exercising more) and after other appropriate interventions. It is important that you continue with the lifestyle changes you have made while taking cilostazol.

2. What you need to know before you take Cilostazol Tarbis

Do not take Cilostazol Tarbis

• if you are allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6).
• if you have a known condition called "heart failure",
• if you have persistent chest pain at rest, or have had a "heart attack" or any heart surgery in the last six months,
• if you have fainted due to a heart condition or severe heart rhythm disorders,
• if you know you have a disorder that increases the risk of bleeding or bruising, for example:

• active stomach ulcers
• stroke in the last six months
• eye problems if you have diabetes
• uncontrolled high blood pressure
• if you are taking aspirin and clopidogrel, or any combination of two or more medicines that may increase your risk of bleeding [consult your doctor or pharmacist if you are unsure]

• severe kidney disease or moderate to severe liver disease,
• if you are pregnant.

Warnings and precautions

Before taking Cilostazol Tarbis, make sure your doctor knows:

• if you have any severe heart problems or any other heart rhythm disorders;
• if you have any blood pressure disorders.

• during treatment with Cilostazol Tarbis, make sure that
• in case you need to undergo surgery, including dental extraction, inform your doctor or dentist that you are taking Cilostazol Tarbis.

Taking Cilostazol Tarbis with other medicines

Before starting to take Cilostazol Tarbis, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

You must specifically inform your doctor if you are taking medicines that are usually taken to treat painful and/or inflammatory conditions in the muscles or joints, as well as if you are taking medicines to reduce blood clotting. These medicines include:

• aspirin
• clopidogrel
• anticoagulant medicines (e.g., warfarin, dabigatran, rivaroxaban, apixaban, or low molecular weight heparins).

If you are taking these medicines with Cilostazol Tarbis, your doctor may need to perform routine blood tests.

Certain medicines may interfere with the effect of Cilostazol Tarbis when taken together. They may increase the side effects of Cilostazol Tarbis or reduce its effectiveness. Cilostazol Tarbis may have these same effects on other medicines. Before starting to take Cilostazol Tarbis, tell your doctor or pharmacist if you are taking:

• erythromycin, clarithromycin, or rifampicin (antibiotics)
• ketoconazole (to treat fungal infections)
• omeprazole (to treat excess stomach acid)
• diltiazem (to treat high blood pressure or chest pain)
• cisapride (to treat certain stomach disorders)
• lovastatin, simvastatin, or atorvastatin (to treat high cholesterol)
• halofantrine (to treat malaria)
• pimozide (to treat mental disorders)
• ergot derivatives (to treat migraines, e.g., ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (to treat seizures)
• St. John's Wort (herbal medicine)

If you are unsure whether this applies to the medicines you are taking, consult your doctor or pharmacist.

Before starting to take Cilostazol Tarbis, tell your doctor or pharmacist if you are taking medicines for high blood pressure, as Cilostazol Tarbis may have an additional blood pressure-lowering effect. If your blood pressure drops too low, you may experience an increased heart rate. These medicines include:

• diuretics (e.g., hydrochlorothiazide, furosemide)
• calcium antagonists (e.g., verapamil, amlodipine)
• ACE inhibitors (e.g., captopril, lisinopril)
• angiotensin II receptor antagonists (e.g., valsartan, candesartan)
• beta-blockers (e.g., labetalol, carvedilol)

It may be possible for you to take these medicines with Cilostazol Tarbis. Your doctor will decide if this is suitable for you.

Using Cilostazol Tarbis with food, drinks, and alcohol

You should take Cilostazol Tarbis tablets 30 minutes before breakfast and dinner.

Always take the tablets with a glass of water.

Pregnancy, breastfeeding, and fertility

DO NOT TAKECilostazol Tarbis during pregnancy.

IT IS NOT RECOMMENDEDto take Cilostazol Tarbis during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cilostazol Tarbis may cause dizziness. If you feel dizzy after taking Cilostazol Tarbis, do not drive or use any tools or machines and inform your doctor or pharmacist.

3. How to take Cilostazol Tarbis

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one 100 mg tablet twice a day (in the morning and at night). No dose adjustment is necessary for elderly patients. However, your doctor may need to prescribe a lower dose if you are taking other medicines that may interfere with the effect of cilostazol.

You should take Cilostazol Tarbis tablets 30 minutes before breakfast and dinner. Always take the tablets with a glass of water.

You may notice the benefits of taking Cilostazol Tarbis 4-12 weeks after starting treatment. At 3 months of treatment, your doctor will assess your progress and may recommend that you stop taking cilostazol if the treatment effect is not sufficient.

Use in children and adolescents

Cilostazol Tarbis is not suitable for children.

If you take more Cilostazol Tarbis than you should

If you have taken more Cilostazol Tarbis tablets than you should, you may experience symptoms such as severe headache, diarrhea, low blood pressure, and irregular heartbeats.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Cilostazol Tarbis

Do not worry if you forget to take a dose. Wait until the next dose and continue with your treatment as usual.

DO NOTtake a double dose to make up for forgotten doses.

If you stop taking Cilostazol Tarbis

If you stop taking Cilostazol Tarbis, the pain in your legs may return or worsen. Therefore, you should only stop taking Cilostazol Tarbis if you experience side effects that require urgent medical attention (see section 4) or if your doctor tells you to do so.

4. Possible side effects

Like all medicines, Cilostazol Tarbis can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you may need urgent medical attention. Stop taking Cilostazol Tarbis and contact a doctor or go to the nearest hospital immediately.

• stroke
• heart attack
• heart problems that can cause difficulty breathing or swelling of the ankles
• irregular heartbeat (new or worsening)
• significant bleeding
• easy bruising
• severe skin disease with blistering of the skin, mouth, eyes, or genitals
• yellowing of the skin or the whites of the eyes due to liver or blood problems (jaundice)

You should also inform your doctor immediately if you have a fever or sore throat. You may need to have blood tests; your doctor will decide on the treatment to be given to you.

The following side effects have been observed in patients treated with Cilostazol Tarbis. If you experience them, you should inform your doctor immediately:

Very common side effects(may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhea

Common side effects(may affect up to 1 in 10 people)

• rapid heartbeats
• heart palpitations
• chest pain
• dizziness
• sore throat
• runny nose (rhinitis)
• abdominal pain
• indigestion
• nausea or vomiting
• loss of appetite (anorexia)
• excess gas or flatulence
• swelling of the ankles, feet, or face
• rash or skin changes
• itching
• bleeding spots on the skin
• general weakness

Uncommon side effects(may affect up to 1 in 100 people)

• heart attack
• irregular heartbeats (new or worsening)
• heart problems that can cause difficulty breathing or swelling of the ankles
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g., from the stomach, eyes, or muscles, nosebleeds, or blood in the sputum or urine)
• decrease in the number of red blood cells in the blood
• dizziness when standing up
• fainting
• anxiety
• difficulty sleeping
• abnormal dreams
• allergic reaction
• pain and discomfort
• diabetes and increased blood sugar levels
• stomach pain (gastritis)
• general malaise

Diabetic patients may be at a higher risk of eye bleeding.

Rare side effects(may affect up to 1 in 1,000 people)

• prolonged bleeding time
• increased platelet count in the blood
• kidney problems

The following side effects have been observed during treatment with Cilostazol Tarbis, but the frequency with which they occur is unknown:

• changes in blood pressure
• decrease in the number of red blood cells, white blood cells, and platelets in the blood
• difficulty breathing
• difficulty moving
• fever
• hot flashes
• eczema and other skin rashes
• decreased sensation in the skin
• tearful or sticky eyes (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cilostazol Tarbis

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cilostazol Tarbis

• The active ingredient is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are cornstarch, microcrystalline cellulose, calcium carmellose,

hypromellose, and magnesium stearate.

Appearance of the product and pack contents

Cilostazol Tarbis 100 mg is a white, round, and scored tablet on one side. Your medicine is supplied in packs of 56 tablets or in hospital packs with 70 (5x14) tablets.

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

08028 Barcelona, Spain

Manufacturer

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans

(Barcelona – Spain)

Date of last revision of this leaflet:November 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/